新型铜Flaxigard宫内节育器与TCu380A宫内节育器的临床对比研究

目的　了解新型铜FlaxigardIUD(CuFixIUD)的避孕效果和副反应 ,以TCu380AIUD为对照组进行临床实验。方法　采用前瞻性、随机分配原则 ,共接收 2 0 0例受试者。结果　 12个月内两组无一例发生妊娠 ,脱落率为每百妇女 10 2和 1 0 ,有明显统计学意义 (P <0 0 5 )。累积使用率为每百妇女 88 8和 97 0 ,两组无统计学意义 (P >0 0 5 )。 2 4个月时累积使用率两组分别为每百妇女 88 8和 93 0 ,36个月时随访率为 10 0 %。妊娠率两组分别为每百妇女 1 0和 3 0 ,因症取出率为每百妇女 2 0和 5 0。最常见的副反应为出血和疼痛。累积使用率分别为每百妇女 85 7和 89 0 ,两组无统计学意义 (P >0 0 5 )。结论　新型铜FlaxigardIUD为一种低妊娠率、高效和长效的IUD。TCu380A仍不失为一种高效、低副反应的IUD。

A comparsion study on new type copper Flaxigard IUD and copper T380A IUD

Objective\ To observe contraception effects and side-effects of new type Copper Flaxigard IUD(Fix IUD)and Copper T 380A IUD(TCu 380A)(control group).Methods\ We performed a prospective randomized clinical trial.Total numbers of 200 cases were recruited in this study.Results\ No case showed pregnancy in 12 months,expulsion rate were 10 2 and 1 0 per 100 women respectively,there was statistically significant difference between these two groups.(P<0 05).The cumulative continuation rate was 88 8 and 97 0 per 100 women respectively at 12 months,there was no statistical significance(P>0 05).The cumulative continuation rate were 88 8 and 93 0 per 100 women at 24 months.Follow-up rate was 100% at 36 months.The pregnancy rates were 1 0 and 3 0 per 100 women respectively and removal rates were 2 0 and 5 0 per 100 women for medical reasons.The most common side-effects were bleeding and pain,the cumulative continuation rate were 85 7 and 89 0 per 100 women,there was no statistical significance between two groups.Conclusion\ The new design of the Flaxigargd IUD showed low pregnancy rate,high efficacy and high acceptabilily rate.The study suggested that T Cu380A also had high efficacy and low side-effect IUD.